The MDR changes will enforce stricter rules on clinical evaluation processes, safety, classification and performance of medical device products
New EU rules for medical device manufacturers have been postponed by a year in a bid to prevent shortages in getting key equipment on the market during the coronavirus pandemic. The Medical Devices Regulation (MDR) was due to be enforceable on 26 May 2020 but will now take effect on 26 May 2021, the European Parliament confirmed.
The legislation, which aims to bring similar safety controls and transparency to medical devices as to those governing medicines, will replace the 1995 Medical Device Directive (MDD).
It has been active since 25 May 2017 but a transition phase is currently underway. The rules will ensure manufacturers and national authorities are more accountable for conducting all the necessary checks across a product’s life cycle.
European Parliament adopted a proposal by the European Commission to delay the full implementation of MDR with 693 votes to one, and two abstentions, on Friday (17 April).
Why the EU Medical Devices Regulation has been postponed
In a statement, the European Parliament said: “Given the current pressure on national health authorities and manufacturers of medical devices, there is a fear that there could be shortages or delays in getting the medical devices needed to fight Covid-19, were they to follow the new rules of the Medical Devices Regulation from May this year.
“The European Parliament is therefore supporting the proposal to postpone the application of this regulation by one year to allow authorities and manufacturers alike to prioritise the fight against the coronavirus pandemic by continuing under current procedures.”
The proposal must be approved by the member states and published in the Official Journal of the European Union before it will enter into force. Sign-off is expected by 26 May.
What is the EU Medical Devices Regulation?
The EU has overall for governing medical device manufacturing, including the mechanical ventilators of which more are being produced to meet shortages for the Covid-19 response, but delegates regulation to individual countries and their own bodies.
These “competent authorities” include the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) – which continues to answer to the EU in the post-Brexit transition period – the Federal Institute for Drugs and Medical Devices (BfArM) in Germany, and National Agency for the safety of Medicines and Health Products (ANSM) in France.
Each body is responsible for ensuring medical devices are safe to use and facilitates patients’ access to devices.
The MDR changes will enforce stricter rules on clinical evaluation processes, safety, classification and performance of medical device products.
In Vitro Diagnostics Medical Devices Regulation (IVDR), which replaces the IVD Directive, is also undergoing a five-year transition period and will become applicable from 26 May as planned.